SeniorPrincipal Medical Writer RemoteHybridIn Office - UK
SeniorPrincipal Medical Writer RemoteHybridIn Office - UK
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Senior/Principal Medical Writer Remote/Hybrid/In Office UK
Job Location: Cambridge UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Trilogy Writing & Consulting an Indegene Company is currently looking to hire Senior/Principal Medical Writers to support our growing company in producing highquality regulatory documentation for the international pharmaceutical industry. At Trilogy you will be part of a team that provides a service that goes beyond just writing. Our writers are integral parts of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As a growing company there is room to develop with us… and your ideas will form our future together. For further insight into who we are and what we do please look at our website ().
Applicants must live in the United Kingdom.
As a Senior/Principal Medical Writer You Will
Only candidates who meet the following requirements will be considered:
Collection and use of personal data in the application process: It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures and are not forwarded to third parties.
Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK and Trilogy Writing & Consulting Inc. in the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under . In the event of revocation we will delete your personal data immediately.
Applicants must live in the United Kingdom.
As a Senior/Principal Medical Writer You Will
- Prepare a variety of clinical regulatory documents (Clinical Study Protocols Clinical Study Reports Clinical Summaries in the CTD format Investigator Brochures IMPDs/INDs scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers as appropriate.
- Ensure that all documents are produced according to agreed timelines monitor and manage project budgets adhere to relevant SOPs and meet the requirements of Trilogy as well as the company’s clients.
- Be responsible for providing documentspecific advice to clients.
- Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
- Project manage the timelines and review cycles of your documents.
- Work in the client’s regulatory document management systems.
- Several years of professional experience actively writing regulatory documents.
- Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols Clinical Study Reports Clinical Summaries in the CTD format Investigator Brochures IMPDs/INDs scientific publications.
- For the Principal Medical Writer level experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application a variation a generic dossier an orphan drug dossier a literaturebased dossier e.g. a fullmixed application under Article 8(3) of Directive 2001/83/EC).
- Experience interacting directly with clients or authors of the documents and coordinating review cycles meetings and project timelines.
- For the Principal Medical Writer level ability and willingness to take on any project for which a Lead Writer is needed.
- Competency in the use of document management systems and review tools.
- Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
- Fluent written and spoken English skills.
- An appreciation for a wellwritten document and an eye for details.
- Excellent proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.
- Must live in Germany Italy Ireland or Portugal.
Only candidates who meet the following requirements will be considered:
- Applicants will work fully remotely or hybrid remotely from our EU office (Frankfurt Germany) depending on location. Freelancers need not apply.
- Submission of documents in English:
- Cover letter specifying how you comply with the experience requirements listed above
- CV
Collection and use of personal data in the application process: It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures and are not forwarded to third parties.
Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK and Trilogy Writing & Consulting Inc. in the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under . In the event of revocation we will delete your personal data immediately.
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
